FDA-Device2024-10-02Class II
Stainless Steel Sims Uterine Sound, Part Number 64-601
CooperSurgical, Inc.
Hazard
During the manufacturing process the devices were laser-marked with the incorrect part number.
Sold states
Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
Affected count
657 units
Manufactured in
95 Corporate Dr, Trumbull, CT, United States
Products
Stainless Steel Sims Uterine Sound, Part Number 64-601
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3189-2024Don't want to check this manually?
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